European Union (Withdrawal) Bill

Lord Hunt of Kings Heath Excerpts

Committee: 8th sitting (Hansard - continued): House of Lords
Monday 19th March 2018 Lords Chamber

[Baroness Finlay of Llandaff (CB)]

My Lords, I support the amendment. I remind the House that many of these inventions in the biomedical sphere actually happen in academic clinical departments. That is where the idea comes—the bright spark of invention. They will establish whatever the device is, and then often it will be a spin-out company from the university that will start to develop it. These new devices are getting smaller and smaller so they are getting into smaller blood vessels or parts of the body to do things that, when I graduated in medicine, were unimaginable.

However, in order for a company to be able to go out and market the device, it has to be able to go through all the rigorous testing procedures that the noble Lord, Lord Warner, outlined. So if we create yet another barrier and another difficulty, the bright sparks are not going to stay here because other universities are already looking at them. Those universities want them and their inventiveness; in Europe they are very attractive commodities. We have to remember that a part of our economy and our economic strategy has depended on our science, and our biological sciences in particular. We have a unique situation with the NHS where we have a broad patient population that is different from some of the other ways in which healthcare is organised and allows such innovation to happen here.

[Lord Hunt of Kings Heath (Lab)]

My Lords, this has been an excellent debate. Here we have a successful and innovative industry with lots of SMEs involved, but their very future is at risk because of the approach that the Government are taking to Brexit. We need to be clear about this. The noble Lord, Lord Empey, talked about CE marking and the notified body. What is crucial is that the CE marking is a logo placed on medical devices to show that they conform to the requirements of the various EU directives. The notified body is an organisation that has been designated by an EU member state to assess whether manufacturers and their medical devices meet the requirements set out in legislation. As part of our being within the EU, the Medicines and Healthcare products Regulatory Agency is the designated competent authority in the UK. That sets out the legal position and why it is so important in terms of both patient safety and the ability of UK companies to do business in the rest of the EU and market some of the most extraordinary machines, devices and developments that have been seen in the world.

Here we come to the point where there is such a risky position for our companies. To take the point of the noble Lord, Lord Deben, we should look at Mrs May’s Mansion House speech, where she referred to the fact that the Government,

“want to explore with the EU, the terms on which the UK could remain part of EU agencies such as those that are critical for the chemicals, medicines and aerospace industries”—

and she mentioned the European Medicines Agency by name, although, extraordinarily, not Euratom, which we will come to debate later this evening and tomorrow. She went on to explain why we should be seeking associate membership of the European Medicines Agency and the other agencies named. She said:

“First, associate membership of these agencies is the only way to meet our objective of ensuring that these products only need to undergo one series of approvals, in one country. Second, these agencies have a critical role in setting and enforcing relevant rules … Third, associate membership could permit UK firms to resolve certain challenges related to the agencies through UK courts … Fourth it would bring other benefits too. For example, membership of the European Medicines Agency would mean investment in new innovative medicines continuing in the UK, and it would mean these medicines getting to patients faster as firms prioritise larger markets when they start the lengthy process of seeking authorisations”.


If ever I have heard a convincing case for remaining a member of the EU, the Prime Minister set it out in her Mansion House speech. The point is the one that the noble Lord, Lord Deben, made. We are going to beg for associate membership. As the Prime Minister said, we will follow the rules and pay the cost, but we will have no say in the rules that are being set. At the moment, the MHRA is one of the most effective negotiators in the EU, so when it comes to medicines safety or devices, the UK has a huge influence. That means a big advantage for UK companies, because it has in mind the interests of the UK as a whole.

We are to throw all this away and be supplicants at the altar of those agencies, because the Government have woken up to the fact that they cannot let those industries go down, so they will have to negotiate associate membership. It will be on EU terms, because they are a lot bigger than we are. We will have to abide by their rules but no longer will we have any say in how those rules are developed. As the noble Lord, Lord Deben, said, we are trying to negotiate the least worst option, but it is a worst option.

It is a wholly depressing picture: this Government seeking to destroy so many of our innovative industries through their obdurate and ignorant approach to the way industry, the UK and the EU work. The noble Lord, Lord Empey, has done us a great service tonight by letting us debate this important issue. It would be nice, would it not, to hear a proper response from the Government to show that they recognise the problems that they are now causing for British industry?

[The Parliamentary Under-Secretary of State, Northern Ireland Office and Scotland Office (Lord Duncan of Springbank) (Con)]

My Lords, this medical device amendment has been deemed a probing amendment, and I can tell the noble Lord, Lord Empey, that I feel well and truly probed by the comments made across the Chamber this evening.

The noble Lord, Lord Deben, made a number of sweeping statements, which of course are accurate, about the response that I must give at this point. He will not be surprised to know that. We have agreed today the beginning of a journey with regard to the transition. I sought confirmation again that medical devices and the CE framework are included in that transition, and indeed they are, so I can give that assurance just now. The noble Lord, Lord Deben, will also be aware that the matters that we have discussed this evening must necessarily be a matter for negotiation. I am sure he will understand why that is so, also.

Were I to stop there, the Committee would rightly be disappointed. This has been a wide-ranging debate touching on a number of points. The noble Lord, Lord Hunt, in summation, raised the Mansion House speech delivered by my right honourable friend the Prime Minister. That speech is a recognition of the importance of mutual recognition, what it means and why it will be important after we leave the European Union.

As a Member of the European Parliament, I sat on the Environment, Public Health and Food Safety Committee when the medical devices and in vitro question was being debated, and I was aware how important that forum was for determining particular standards. I am also aware of the importance of the United Kingdom’s innovation in medical devices. It is global in its reach and import and is extraordinary in what it can achieve. I am aware that, as we exit the European Union, we must secure mutual benefit to both sides. I do not accept the assertion that this is a moment when big means right. We are seeking an outcome that is right for those who would seek the comfort and necessity of what those medical devices must be and can achieve for them.

[Lord Hunt of Kings Heath]

Will the Minister explain to noble Lords what effect mutual recognition would have? Can he explain how the UK will have as much influence on those rules in the future, outside the EU, as it does now, as a key member of it? Or does it mean that, in effect, we will simply have to follow the rules set by the EU?

[Lord Duncan of Springbank]

I thank the noble Lord for his question. I am again reminded of the importance of the United Kingdom’s academic sector and the academic excellence which it creates, not just in the wider area of science but specifically in medical science. I am aware of how important that innovation is and believe that, right now, it should be able to speak for itself in the negotiations and discussions in terms of the wider recognition and import of what they represent.

I am conscious that, as we embrace the challenges which lie ahead—

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[Baroness Neuberger (CB)]

My Lords, I support this amendment, which is in the name of my noble friend Lord Warner and others. It has been nicknamed, as everybody knows, the “do no harm” amendment although perhaps, more accurately, it should be the “do not roll back” amendment. I declare interests as an honorary fellow of the Faculty of Public Health—I too wish to thank the faculty and staff for its briefing—and as a former chief executive of the King’s Fund.

Much has already been argued, and I will not repeat any of that; it is late, and there are more amendments to come. However, I lay on the line that, as was asserted by the noble Lord, Lord Deben, in the debate on the amendment on medical devices, this is a moral issue. “First, do no harm” is a moral imperative taught to all medical and healthcare students, and this amendment makes it clear that those hard-won advances in public health as a result of EU legislation and regulation must not be rolled back, for whatever reason, be they air quality, tobacco packaging, alcohol pricing or whatever else that has been raised from around the House. The Government have given assurances that all will be well. However, as my noble friend Lord Warner has already said, we need more. We need this in the Bill. I cannot remember the public health community coming so strongly together on anything since tobacco packaging. This matters hugely to those who work in the area of public health, and it should matter to all of us. There is concern out there, and a moral imperative in the amendment. I support it strongly.

[Lord Hunt of Kings Heath]

My Lords, this has been an interesting debate, and we have identified some of the challenges that we face in public health: air quality, environmental standards, food standards, accidents, infectious diseases and, indeed, huge health inequalities. I listened with interest to the noble Baroness, Lady Oppenheim-Barnes. Overall, I disagreed with her. Of course, you can pick out some regulations from the EU with which one might disagree or think that they do not go far enough, and she identified an issue around labelling. Overall, however, the EU has been generally helpful and a force for improvement in public health. I mention in particular air quality, because that is one clear example where it has pressed this country hard on our very poor performance. Governments have started to do something about it only because of the fines we face. There are other examples as well.

The fear expressed so well by noble Lords—I too pay tribute to the Faculty of Public Health for its briefings on this—is that without EU law, and in the context of already significant reductions in public health budgets, we will see a gradual erosion over time of our important public health legislation. The noble Baroness, Lady Finlay, and others mentioned food safety as an example. The Minister will no doubt tell us that he cannot say anything substantive because of the process of negotiations; he has said that a few times before. However, one of the fears clearly is that in the Government’s haste to negotiate a deal with the US—they are desperate to do so, for obvious reasons—when it comes to it, things like some of the food standards we have at the moment will go by the board. We know that that will happen because they have to produce a US trade deal; they have no option but to do it. They are so weak compared to the US in terms of the negotiation that it is quite likely that some of those standards will have to be thrown away.

That is why this amendment has been brought forward tonight. Ministers have helpfully discussed this amendment in meetings with some stakeholders. I know Ministers may say that the Secretary of State already has the powers set out in the amendment. However, as the noble Lord, Lord Warner, said, the amendment would place a duty on the whole of the Government to do no harm. That is a very important distinction. Importantly, it would also place a duty on other public authorities, including the devolved nations, so I believe that it goes further than current legislation. It is relevant to the European Union (Withdrawal) Bill, not just to a theoretical health and social care Bill which may be introduced at some point.

Other noble Lords have talked about the Lisbon treaty and the impact upon it. The amendment essentially seeks to ensure that there is a legal precedent and interpretive guidance on which to draw when determining the meaning of the proposed new clause, but, as I understand it, it does not seek to preserve EU law and regulation. Therefore, it would be for the British courts, on the basis of our doctrines of parliamentary sovereignty, to decide the future interpretation of the law.

This has been a very important debate. The Minister has to recognise that there is real concern that the Government’s desire to negotiate agreements with other countries will lead to them having to agree to reduce some of our essential public health standards. This amendment seeks to provide a guarantee and assurance that this will not happen. We should very much welcome it.

[Lord Duncan of Springbank]

I thank the noble Lord for his comments. I will start where he finished: no, we are not going to do that. I am afraid that is not the Government’s purpose. There will be no rollback of these standards because they are at the heart of what we believe to be right and proper. A number of noble Lords have implied that what has been proposed will be the case. I assure them that is not the case.

My noble friend Lady Chalker is right to stress the leadership role that the United Kingdom has long had in the area of public health. Indeed, that leadership role has been a beacon to not only the EU but its member states. As someone who currently lives in Edinburgh, I recognise the role that Scotland has had in pushing forward boundaries which are only now being adopted in certain parts of the world. It is important to stress that we are not in any way diminishing our regard for public health. Indeed, in bringing across the corpus of European law, those matters will rest in our statute book and will therefore be removable only by the other place and by this place.

Before I address some of the more substantive points, it is important once again to look at the EU itself, mostly in the area of public health. The noble Lord should be aware that public health has not been a core competence of the EU. Indeed, many of the aspects of public health have rested elsewhere within the statute books. Noble Lords will be aware that we have known about the pernicious and deadly impact of tobacco for many years, yet it is only in the last five years that the EU has phased out subsidies for tobacco growers.

I was a member of the European Parliament and sat on the environment committee. I also sat on the committee that investigated a scandal that came to be known as “dieselgate”. Noble Lords will be aware of exactly what that represented. At the heart of the EU, a major organisation installed cheap devices in vehicles that were specifically intended to undermine the core air quality standards. We should again remember that that was uncovered by an American public body, not by the EU’s body, which is in itself a borderline scandal. Further, we must also recognise that Volkswagen has compensated car owners in the US but has not in any way compensated car owners in the EU.

I am reminded also of the traceability of food and the horsemeat scandal, which riddled the EU. High standards are important only if they are met, and they must be met in each and every instance. Far too often we have found across the EU some of the most rigorous standards on paper that there could ever be, yet their enforcement is dreadful and woeful. Indeed, I am nearly certain that when we leave the EU the mean standard of public health will fall in the remaining states, so important is the contribution that we make to the wider question of public health.

When we look at the role of global standards and something like the recent Ebola outbreak, it was not the EU that pushed at that standard but France and the UK. They recognised an obligation to deliver against that pernicious pandemic. I believe we also need to recognise that the UK has been at the cutting edge of driving forward public health.

The noble Lord, Lord Warner, said that I might suggest that his amendment was vague. It is not vague; it simply duplicates exactly what the Government—indeed, not just this Government but every Government—have long said and long held to be dear. At the heart of good government must be the preservation of public health. It must be a cornerstone not just in the UK Government but in the Governments of the devolved Administrations, which in some respects have been brought into the ambit of the report. We need to recognise that.

Perhaps I may touch upon some of the other issues that have been brought into this wide-ranging debate. I reiterate that many of the aspects that we are touching on here will necessarily be part of ongoing negotiations, but I assure noble Lords that it is this Government’s intention to secure the highest possible engagement on matters of wider public health. I thank the noble Lord, Lord Patel, for bringing up a number of the areas that I believe the Government need to look at carefully—how we continue our collaboration, how we ensure that we can co-operate and how we can maintain that high standard. We can do so by sharing practice on both sides, because we both have a great deal to contribute and each will be the poorer for the absence of that collaboration.

It important for me to stress that the Secretary of State for Health and Social Care has a statutory duty under the National Health Service Act 2012 to protect the health of the public. A number of noble Lords have raised that, as indeed has the briefing from a number of sources, not least the Royal College of Physicians of the United Kingdom. Of course we are going to argue that the Secretary of State for Health and Social Care already has these powers, and it is his intention to hold them to the highest possible standard. I stress that, although there is an equivalent duty under the NHS—

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[Lord Hunt of Kings Heath]

My Lords, that was a mischievous intervention by my noble friend, which the noble and learned Lord has dealt with eloquently from his place.

It seems to me that this is a very important question and the noble and learned Lord is surely right: obviously, this country developed the first peacetime nuclear plant at Sellafield—or Windscale, or Calder Hall, even—and we blew that. We blew our leadership completely. We have though, with nuclear fusion, still great potential and we are at risk of throwing that away as well. That is why this is such an important amendment and discussion. It would be a tragedy if we lost the current expertise that we have, and I hope the noble Baroness will be able to say something about that.

I echo what my noble friend Lord Liddle said: we have had a number of debates about Euratom now, but there has never been a straight explanation as to why the Government decided they had to leave Euratom even though we were members of Euratom and Euratom existed before the EU. The noble Viscount, Lord Trenchard, is critical of Euratom, but the fact is that the Government—his Government—are saying that we want to maintain nuclear safeguards in consistency with Euratom, but we cannot do so at the beginning so all we can promise to do is to maintain the standards of the IAEA, which as the Office for Nuclear Regulation told the Public Bill Committee in the other place will mean fewer inspections at lower intensity. So we have this remarkable situation where the Government have decided, for no reason that anyone can understand, that we are going to leave Euratom, but because we think Euratom is such a good institution our aspiration is to keep to Euratom standards. However, we cannot do it: because the UK cannot get the number of inspectors in place to maintain those standards, we are going to keep to the reduced standards of the IAEA. We find ourselves in a quite extraordinary position.

I turn to the speech given by the Prime Minister at the Mansion House just a couple of weeks ago. She differentiates between some EU agencies and others. So, in her speech, she says:

“We will also want to explore with the EU, the terms on which the UK could remain part of EU agencies such as those that are critical for the chemicals, medicines and aerospace industries: the European Medicines Agency, the European Chemicals Agency, and the European Aviation Safety Agency”.


However, when she talks about energy, she simply talks about having “a close association” with Euratom. I ask the noble Baroness why, when is it is quite clear that the Government are going for associate membership of a number of agencies, such as the EMA, which means accepting their rules but having no influence over those rules, in the case of Euratom, which I would have thought, frankly is as crucial as the European Medicines Agency or the European Chemicals Agency, all we are seeking to do is to have a close association. It would be very helpful if the noble Baroness would explain what is it about Euratom that the Government seem so determined to leave and not seek associate membership, when it is an agency whose standards we aspire to keep. It is a puzzle that, despite the help of Ministers on this Bill and the Nuclear Safeguards Bill, we still do not understand.

[Lord Teverson]

Before the Minister stands up, perhaps I might ask for some clarification. The draft transition agreement was published today. I read through what it says on Euratom—it is in green, meaning that it is completely agreed apart from any legal, bureaucratic changes that might be made, yet I am still unclear from that document whether during the transitional period the ONR is responsible to the International Atomic Energy Agency for safeguarding in the UK or Euratom continues to be responsible under the acquis. I ask the Minister to clarify that tonight—it must have been agreed because it is in green—so that we are clear for the debate tomorrow.